About the Role
Rxhere LLC is seeking an experienced and highly proficient 503A Non-Sterile Laboratory Manager to oversee and optimize daily compounding operations within our non-sterile facility. This leadership role is responsible for ensuring full compliance with USP <795>, USP <800>, Virginia Board of Pharmacy regulations, and all applicable federal requirements. The ideal candidate has a strong technical foundation in pharmaceutical compounding, proven management experience, and a commitment to quality and patient safety.
Key Responsibilities
– Direct, supervise, and manage the daily activities of the non-sterile 503A compounding laboratory.
– Ensure full compliance with USP <795> and USP <800> standards, as well as state and federal regulations.
– Develop, implement, and maintain SOPs related to compounding practices, quality assurance, safety, and documentation.
– Train, mentor, and supervise compounding staff; ensure ongoing competency and adherence to best practices.
– Oversee preparation of non-sterile compounded preparations, ensuring accuracy, quality, and regulatory compliance.
– Maintain meticulous documentation including formulation records, logs, BUD assignments, verification, and cleaning records.
– Conduct routine internal audits and lead corrective actions to address deficiencies.
– Manage equipment maintenance, calibration, and any required environmental monitoring.
– Maintain proper handling, storage, and documentation for hazardous drugs in accordance with USP <800>.
– Support quality and regulatory teams during inspections and accreditation activities.
– Ensure efficient inventory management and procurement of compounding materials.
Qualifications
– Minimum 3–5 years of non-sterile pharmaceutical compounding experience in a 503A setting (required).
– Deep knowledge of USP <795> and USP <800> standards.
– Leadership or supervisory experience strongly preferred.
– Active Pharmacist or Pharmacy Technician license in Virginia (as applicable).
– Strong understanding of compounding documentation, quality processes, and safety protocols.
– Excellent organizational, analytical, and communication skills.
Preferred Skills
– Experience with quality improvement initiatives and audit readiness.
– Familiarity with compounding software and electronic documentation workflows.
– Ability to work accurately in a fast-paced, compliance-driven environment.